Examining the Effects of Video-game Exercise on Mobility and Brain Plasticity in Individuals With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Examining the Effects of Dance, Dance Revolution on Mobility, Brain Plasticity and Cognition in Individuals With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780792
• Other study ID #: 2011H0048
• Status: Completed
• Phase: N/A
• First received: November 7, 2012
• Last updated: April 5, 2017
• Start date: August 2011
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dance Dance Revolution (DDR) may offer an innovative and highly effective format for delivering exercise programs to people with multiple sclerosis (MS). It is a fun, engaging and interactive video game that requires players to move their feet to targets while matching the rhythm of a song. In addition, DDR, involving both aerobic exercise and cognitive training, is an ideal intervention for improving cognitive functioning in those with MS. The purpose of this pilot study is to examine the use of DDR as a novel and highly specific exercise intervention to improve mobility and cognition among individuals with MS.

Description:

Dance Dance Revolution (DDR) may offer an innovative and highly effective format for delivering exercise programs to people with MS. It is a fun, engaging and interactive video game that requires players to move their feet to targets while matching the rhythm of a song. In addition, DDR, involving both aerobic exercise and cognitive training, is an ideal intervention for improving cognitive functioning in those with MS. The purpose of this pilot study is to examine the use of DDR as a novel and highly specific exercise intervention to improve mobility and cognition among individuals with MS. We will be guided by the following three specific aims and hypotheses:

Specific Aim 1: Determine if an eight-week exercise program administered using DDR improves dynamic balance in people with MS relative to a wait-list control group.

Hypothesis 1: Dynamic balance as measured by the Berg Balance Scale will be more improved with the DDR intervention than the wait-list control group.

Specific Aim 2: Determine if the DDR intervention, combining fitness and cognitive training, over the course of an eight-week intervention, will have a more positive effect on domains of processing speed and executive control, than a wait-list control group.

Hypothesis 2: The DDR group relative to the wait-list control group, will show significant improvement in cognitive functioning as assessed by the Paced Auditory Serial Addition Test (PASAT), a measure of processing speed, and executive functioning. Specifically, we hypothesize that given severe deficits in processing speed and executive control, participation in a DDR intervention, will result in a significant improvement on the PASAT, a widely used measure to assess cognitive functioning in patients with MS.

Specific Aim 3: We will also examine whether improvements in cognitive processes engendered by DDR on the PASAT will be supported by changes in underlying neural circuits, as inferred from patterns of event-related functional magnetic resonance imaging (fMRI) activation obtained in a 3 Tesla scanner.

Hypothesis 3: Improvements in cognition as indexed by higher accuracy scores and faster reaction time on the PASAT, will be accompanied by a change in the recruitment of underlying neural processes as inferred from functional magnetic resonance imaging. MS participants in the DDR group will show an increase in recruitment of the attentional network, and more specifically the prefrontal and parietal cortices, cortical regions responsible for successful performance on the PASAT task.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

Inclusion Criteria:

• Expanded Disability Status Score of < 5 and a diagnosis of relapsing-remitting multiple sclerosis

Exclusion Criteria:

• other neurological or orthopedic diagnosis that limits ambulation, age 30-59

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Dance Dance Revolution video game play
Individuals play dance dance revolution 3 times a week for 8 weeks

Locations

Country	Name	City	State
United States	The Ohio State University Atwell Hall	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale	The Berg Balance scale consists of 14 functional activities that test static and dynamic balance. Each item is scored on a scale of 0-4 with higher scores indicating better balance	after 8 weeks
Primary	PASAT	The PASAT is a measure of sustained attention, working memory and information processing speed.	after 8 weeks
Secondary	4 square step test	requires a person to step rapidly in a multi-directional pattern over a cane. It predicts fallers	after 8 weeks
Secondary	The Activities Specific Balance Confidence Scale	Measures fear of falling. Subjects rate their balance confidence on 10 items.	after 8 weeks
Secondary	GAITRite	individuals walk on a computerized carpet that records spatiotemporal aspects of gait such as velocity and stride length.	after 8 weeks
Secondary	6 minute walk test	subjects walk for 6 minutes and distance walked is measured	Immediately prior to starting the intervention/control period,, after 8 week intervention/control period and then at an 8 week follow up
Secondary	physical activity	subjects wear an accelerometer for 5 days which records how active they are.	after 8 weeks
Secondary	multiple sclerosis quality of life inventory	the MS quality of life inventory is filled out to measure the impact of MS on the individuals quality of life.	after 8 weeks
Secondary	fMRI	individuals will go into an MRI and undergo neuropsychological and motor testing to examine for neuroplasticity	after 8 weeks